cerebral aneurysm treatment: modern neurovascular techniques · intracranial aneurysms, these...

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Cerebral aneurysm treatment: modern neurovascular techniques Bowen Jiang, 1 Michelle Paff, 2 Geoffrey P Colby, 1 Alexander L Coon, 1 Li-Mei Lin 2 To cite: Jiang B, Paff M, Colby GP, et al. Cerebral aneurysm treatment: modern neurovascular techniques. Stroke and Vascular Neurology 2016;00: e000027. doi:10.1136/svn- 2016-000027 Received 19 June 2016 Revised 26 July 2016 Accepted 28 July 2016 1 Department of Neurosurgery, Johns Hopkins University School of Medicine, The Johns Hopkins Hospital, Baltimore, Maryland, USA 2 Department of Neurosurgery, University of California, Irvine School of Medicine, UC Irvine Medical Center, Orange, California, USA Correspondence to Dr Li-Mei Lin; [email protected] ABSTRACT Endovascular treatment of cerebral aneurysm continues to evolve with the development of new technologies. This review provides an overview of the recent major innovations in the neurointerventional space in recent years. HISTORY OF ENDOVASCULAR TREATMENT The neurosurgical treatment of intracranial aneurysms dates back to 1937, when Dandy 1 described microsurgical obliteration of a posterior communicating artery aneurysm. For decades, microsurgical clipping remained the gold standard and foremost modality for treatment of cerebral aneurysms. Endovascular therapies emerged in the 1990s with the advent of the Guglielmi detachable coil system. This system established neuroin- tervention as a new eld, with multiple rando- mised clinical trials demonstrating the efcacy and safety of coil embolisation. 2 3 Despite these early favourable results, postcoiling aneurysm recanalisation remained a challenge in the eld. For instance, Raymond et als 4 experience with 501 cerebral aneurysms treated with endovascular coiling demon- strated that complete angiographic occlusion rate was approximately only 38% at 1-year follow-up. The data were further corroborated by Gory and Turjman, 5 whose prospective, multicentre European study of 404 aneurysms treated with Nexus detachable coils (ev3-Covidien, Irvine, California, USA), showed 22% neck remnant and 30% aneurys- mal remnant, with a 17.7% recanalisation rate and 21.6% thrombosis rate at 13 months angiographic follow-up. To address these shortcomings, the neuroen- dovascular space quickly experienced signicant technological advancements aimed at improv- ing the different properties of a coil, including coil lengths, shapes, softness and detachment zones. These developments have translated to improvements in clinical outcomes of cerebral aneurysms treated with coiling. For example, HydroCoils (MicroVention, Tustin, California, USA) have allowed for treatment of more complex aneurysmal congurations with a reduction in recurrence rates compared with bare-platinum coils. 67 Additionally, new neu- roendovascular devices such as intracranial stents and balloons were developed to augment coil embolisation. In balloon- assisted coil embolisation, typically a compli- ant balloon is positioned across the neck of the aneurysm to provide a scaffold protecting the parent artery while coils are deployed through a microcatheter into the aneurysm sac. This reduces the risk of coil prolapse into the parent vessel and can also provide immediate protection in an event of intra- procedural aneurysm rupture during the coiling due to the ability to achieve endovas- cular proximal control with balloon ination. Comparatively, stent-assisted coil embolisa- tion was developed to improve the occlusion rate and coil packing density of wide-necked as well as large and giant aneurysms. During this process, the stent (similar to a balloon) is positioned across the aneurysm neck, pro- viding a scaffold to protect the parent artery. This minimises coil loop prolapse and allows for higher density coil packing, leading to a reduction in recurrence rates and higher rates of angiographic occlusion. 810 Despite these technological advancements in coil embolisation, aneurysms with large diameters (>10 mm), wide necks, unfavour- able dome-to-neck ratios (<2) and fusiform conguration remain therapeutic challenges and dilemmas, with as high as >20% poor outcome (aneurysm recurrence or treat- ment-related morbidity/mortality) associated with the management of large/giant aneur- ysms. 11 12 To meet these challenges, device innovations have ushered in new therapeutic concepts, including ow diversion and intra- saccular ow disruption. FLOW DIVERSION REVOLUTION The concept of ow diversion serendipit- ously stemmed from the lessons garnered from stent-assisted coil embolisation. When research studies demonstrated that denser Jiang B, et al. Stroke and Vascular Neurology 2016;00:e000027. doi:10.1136/svn-2016-000027 1 Open Access Review Copyright 2016 by BMJ Publishing Group Ltd. on June 10, 2020 by guest. Protected by copyright. http://svn.bmj.com/ Stroke Vasc Neurol: first published as 10.1136/svn-2016-000027 on 17 August 2016. Downloaded from

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Page 1: Cerebral aneurysm treatment: modern neurovascular techniques · intracranial aneurysms, these aneurysms only encompass a small fraction of all intracranial aneurysms. In contrast,

Cerebral aneurysm treatment:modern neurovascular techniques

Bowen Jiang,1 Michelle Paff,2 Geoffrey P Colby,1 Alexander L Coon,1 Li-Mei Lin2

To cite: Jiang B, Paff M,Colby GP, et al. Cerebralaneurysm treatment:modern neurovasculartechniques. Stroke andVascular Neurology 2016;00:e000027. doi:10.1136/svn-2016-000027

Received 19 June 2016Revised 26 July 2016Accepted 28 July 2016

1Department ofNeurosurgery, Johns HopkinsUniversity School ofMedicine, The Johns HopkinsHospital, Baltimore,Maryland, USA2Department ofNeurosurgery, University ofCalifornia, Irvine School ofMedicine, UC Irvine MedicalCenter, Orange, California,USA

Correspondence toDr Li-Mei Lin;[email protected]

ABSTRACTEndovascular treatment of cerebral aneurysm continuesto evolve with the development of new technologies.This review provides an overview of the recent majorinnovations in the neurointerventional space in recentyears.

HISTORY OF ENDOVASCULAR TREATMENTThe neurosurgical treatment of intracranialaneurysms dates back to 1937, when Dandy1

described microsurgical obliteration ofa posterior communicating artery aneurysm.For decades, microsurgical clipping remainedthe gold standard and foremost modalityfor treatment of cerebral aneurysms.Endovascular therapies emerged in the 1990swith the advent of the Guglielmi detachablecoil system. This system established neuroin-tervention as a new field, with multiple rando-mised clinical trials demonstrating the efficacyand safety of coil embolisation.2 3 Despitethese early favourable results, postcoilinganeurysm recanalisation remained a challengein the field. For instance, Raymond et al’s4

experience with 501 cerebral aneurysmstreated with endovascular coiling demon-strated that complete angiographic occlusionrate was approximately only 38% at 1-yearfollow-up. The data were further corroboratedby Gory and Turjman,5 whose prospective,multicentre European study of 404 aneurysmstreated with Nexus detachable coils(ev3-Covidien, Irvine, California, USA),showed 22% neck remnant and 30% aneurys-mal remnant, with a 17.7% recanalisation rateand 21.6% thrombosis rate at 13 monthsangiographic follow-up.To address these shortcomings, the neuroen-

dovascular space quickly experienced significanttechnological advancements aimed at improv-ing the different properties of a coil, includingcoil lengths, shapes, softness and detachmentzones. These developments have translated toimprovements in clinical outcomes of cerebralaneurysms treated with coiling. For example,HydroCoils (MicroVention, Tustin, California,USA) have allowed for treatment of more

complex aneurysmal configurations with areduction in recurrence rates compared withbare-platinum coils.6 7 Additionally, new neu-roendovascular devices such as intracranialstents and balloons were developed toaugment coil embolisation. In balloon-assisted coil embolisation, typically a compli-ant balloon is positioned across the neck ofthe aneurysm to provide a scaffold protectingthe parent artery while coils are deployedthrough a microcatheter into the aneurysmsac. This reduces the risk of coil prolapseinto the parent vessel and can also provideimmediate protection in an event of intra-procedural aneurysm rupture during thecoiling due to the ability to achieve endovas-cular proximal control with balloon inflation.Comparatively, stent-assisted coil embolisa-tion was developed to improve the occlusionrate and coil packing density of wide-neckedas well as large and giant aneurysms. Duringthis process, the stent (similar to a balloon)is positioned across the aneurysm neck, pro-viding a scaffold to protect the parent artery.This minimises coil loop prolapse and allowsfor higher density coil packing, leading to areduction in recurrence rates and higherrates of angiographic occlusion.8–10

Despite these technological advancementsin coil embolisation, aneurysms with largediameters (>10 mm), wide necks, unfavour-able dome-to-neck ratios (<2) and fusiformconfiguration remain therapeutic challengesand dilemmas, with as high as >20% pooroutcome (aneurysm recurrence or treat-ment-related morbidity/mortality) associatedwith the management of large/giant aneur-ysms.11 12 To meet these challenges, deviceinnovations have ushered in new therapeuticconcepts, including flow diversion and intra-saccular flow disruption.

FLOW DIVERSION REVOLUTIONThe concept of flow diversion serendipit-ously stemmed from the lessons garneredfrom stent-assisted coil embolisation. Whenresearch studies demonstrated that denser

Jiang B, et al. Stroke and Vascular Neurology 2016;00:e000027. doi:10.1136/svn-2016-000027 1

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coil packing with less coil prolapse into the parent vesselcorrelated with improved clinical and radiographic out-comes, fluid dynamic analysis revealed that endovascularstents actually accelerated aneurysmal thrombosis andalteration in blood flow into the aneurysm from theparent vessel.9 13 14 Flow diversion is fundamentallybased on two concepts illustrated in figure 1: (1) theplacement of a high-mesh density stent in the parentvessel disrupts blood flow into the aneurysm and (2) thestent provides a scaffold for which endothelium cangrow, subsequently isolating the aneurysm from theparent circulation.15 Flow diversion thus allows forprogressive intra-aneurysmal thrombosis over time withsubsequent radiographic obliteration of the aneurysm.The advantage of endoluminal flow diversion over endo-saccular coiling is the ability to treat the weakenedabnormal arterial wall by providing a scaffold for neoen-dothelialisation to occur. This neoendothelialisationprocess results in a durable occlusion of the aneurysmthat often provides a curative outcome as compared withthe known recurrence associated with coiling. Figure 2demonstrates a case example of a large left-sided cavern-ous internal carotid artery (ICA) aneurysm that wastreated with a flow diverter deployed within the parentICA and evidence of complete aneurysm occlusion onthe 6-month follow-up angiography. Additionally, withthe endoluminal approach, the aneurysm sac does notneed to be accessed during the treatment, which subse-quently eliminates the risk of intraprocedural aneurysmrupture inherent with endosaccular coiling.

The first introduction of flow diversion into theneuroendovascular space was in 2007, with the inventionof the Pipeline Embolization Device (PED; MedtronicNeurovascular, Irvine, California, USA).16 Since then,a plethora of flow diverters have entered the neurointer-ventional field including the Silk flow diverter (BaltExtrusion, Montmorency, France), Flow-RedirectionEndoluminal Device (FRED; MicroVention, Tustin,California, USA), Surpass (Stryker Neurovascular,Freemont, California, USA), Tubridge (MicroPortMedical, Shanghai, China) and p64 Flow ModulationDevice (Phenox, Bochum, Germany). Most of these flowdiverters are commercially available in Europe andSouth America. In the USA, however, PED is the onlyavailable flow diverter after its approval by the Food andDrug Administration (FDA) in 2011.17

Pipeline Embolization DeviceThe PED is a braided mesh designed with 48 strandsconsisting of 25% platinum–tungsten and 75% cobalt–chromium–nickel alloy. When fully deployed, the PEDprovides 35% metallic surface-area coverage with poresize of 0.02–0.05 mm2 at nominal vessel diameter.15 ThePED is available in sizes ranging from 2.5 to 5.0 mm indiameter (in 0.25 mm increments) and 10–35 mm inlength (in 2 mm increments from 10 to 20 mm, and5 mm increments from 20 to 35 mm). The PED deliverysystem comes attached to a 0.016″ diameter stainlesssteel delivery wire, with the segment where it is mounted

Figure 1 Flow diversion concept: placement of a high-mesh density stent (flow diverter) in the parent vessel disrupts blood flow

into the aneurysm (A and B), allowing for progressive intra-aneurysmal thrombosis over time with subsequent obliteration of the

aneurysm (C and D). Additionally, the flow diverter provides a scaffold for neoendothelialisation, which treats the weakened

abnormal arterial wall and isolates the aneurysm from the parent circulation resulting in durable occlusion of the aneurysm (E).

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being 0.008″ thick. It is delivered via a 0.027″ deliverymicrocatheter, such as the Marksman (MedtronicNeurovascular, Irvine, California, USA) or a similar sizemicrocatheter. The second-generation PED, namedPipeline Flex (PED Flex), received the European CEmark of approval in March 2014 and subsequentlyreceived FDA approval in February 2015. Its designincludes numerous delivery system changes to enhancedevice opening and provide additional safety with aresheathing feature.18 The PED’s on-label usage as dic-tated by the FDA is limited to the treatment of large orgiant (≥10 mm) wide-necked intracranial aneurysmsfrom the petrous to the superior hypophyseal segmentsof the ICA.17

Clinical experience worldwide with PED has demon-strated the effectiveness, durability, safety and cost-effect-iveness of endovascular endoluminal reconstructionprimarily in large and giant aneurysms. Initial reportsfrom Buenos Aires and Budapest series demonstratedcomplete radiographic occlusion rates in the 90–93%range at 6 months follow-up angiogram.19 20 Thesestudies paved the way to the PED for the IntracranialTreatment of Aneurysms Trial (PITA), which showed93.3% angiographic occlusion rates at 6 months (28 of30 aneurysms), with 6.5% of patients having majorstroke or neurological complication (2 of 31 patients).16

Similarly, the PED for Uncoilable or Failed Aneurysms(PUFs) multicentre clinical trial that led to the FDA pre-market approval of the PED in 2011, demonstrated in108 patients across 10 prospective centres high rates ofprimary efficacy (81.8% of aneurysm with completeocclusion at 6 months) with low complication rate (5.6%of patients with major strokes or neurological injury at180 days).21 Taken together, all of the trials demon-strated relatively high rates of aneurysm occlusion (81.8–93.3%) with low rates of major morbidity and mortality(0–6.5%).16 19–21

Other subsequent studies for the on-label usage ofPED have corroborated the trial data at the institutionallevel, with similar rates of radiographic success with lowrates of postprocedural morbidity and mortality.22

Studies have further demonstrated the cost-effectivenessof using PED as advantageous over traditional

stent-assisted coiling of large anterior circulation aneur-ysms (27.1% cost reduction per millimetre of aneurysmtreated in the PED group compared with stent-assistedcoiling).23 Treatment of large and giant proximal ICAaneurysms using PED also requires less radiation, lessfluoroscopy time and less contrast administration thanstandard coiling techniques, with an average radiationdose of 2840 mGy with PED treatment compared with4010 mGy with traditional coiling techniques.24

Although PED is FDA approved for large and giantintracranial aneurysms, these aneurysms only encompassa small fraction of all intracranial aneurysms. In contrast,over 80% of all cerebral aneurysms found in the generalpopulation are <10 mm in size.25 26 There is considerabledocumentation in the literature that the majority of rup-tured aneurysms are smaller than 10 mm.27 Treatment ofsmall aneurysms (<10 mm) with flow diverters may beadvantageous over traditional endosaccular modalities.Lin and colleagues retrospectively reviewed a prospective,single-centre aneurysm database to identify 41 patientswith 44 PED cases. In this series, mortality was reportedin 2.3% while by 6 months post-PED implantation, angio-graphic success was observed in 80%.28 This experiencewith PED treatment for small ICA aneurysms is compar-able to the few published reports on this experience, withmortality range of 0% observed by Chan et al,29 and 11%observed by Lubicz et al,30 which is comparable with thePED experience for large and giant aneurysms withreported mortality rates up to 5.5%.A wealth of experience has been garnered in the neu-

roendovascular space with the PED since its introduc-tion, such that treatment of large and giant ICAaneurysms with flow diversion is now a widely acceptedstandard approach. As a result of the success with PEDtreatment of these complex aneurysms, there is also anexpansion of interest and data supporting the safety aswell as efficacy of PED treatment in an ‘off-label’manner with small anterior circulation aneurysms aswell as select posterior circulation aneurysms.31–33

Surpass flow diverterThe Surpass flow diverter is similar to the PED in designconsisting of a braided mesh constructed of cobalt–

Figure 2 Flow diversion treatment of a large left cavernous aneurysm with complete occlusion of the aneurysm demonstrated at

6-month follow-up angiogram.

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chromium alloy intertwined with platinum–tungstenwires for visibility. Compared with PED, the Surpass hasa lower porosity and is designed to maintain constantpore density over various diameters of the device.Additionally, the Surpass flow diverter exists in fewersizes with only 3, 4 and 5 mm diameter options. The 3and 4 mm devices have 72 wires, and the 5 mm device has96 wires. Unlike the PED, the Surpass device is preloadedat the distal end of a microcatheter delivery system thatconsists of a 0.040″ inner diameter (ID) delivery mico-catheter and pusher. The entire Surpass delivery system isadvanced over a 0.014″ microwire inserted through thepusher. The implant is deployed by a combination ofadvancing the pusher and unsheathing themicrocatheter.34

Wakhloo et al35 reported the largest study on safetyand efficacy of Surpass, with a prospective, multicentre,non-randomised, single-arm design of 165 patients with190 intracranial aneurysms of the anterior and posteriorcirculations enrolled from 24 centres. Successful deploy-ment of the Surpass flow diverter was observed in 98%of the aneurysms. Follow-up angiography available in158 (86.8%) intracranial aneurysms showed 100% occlu-sion in 75% of the cases at radiographic follow-ups.Permanent neurological morbidity and mortality were6% and 2.7%, respectively. Morbidity occurred in 4%and 7.4% of patients treated for aneurysms of the anter-ior and posterior circulation, respectively. These datademonstrate that the clinical safety profile is similar tothat of stent-assisted coil embolisation and PED treat-ment with high rates of radiographic occlusion.35

Colby and colleagues reported the initial NorthAmerican experience with Surpass. In this study, 20patients with ICA aneurysms ≥10 mm with ≥4 mm neckwere treated as part of the Surpass IntraCranialAneurysm Embolization System Pivotal Trial (the SCENTtrial; Stryker).36 The Surpass device was implanted in19/20 (95%) cases. Of 19 cases, a single device was usedin 18 cases (95%) and two devices in only 1 case (5%).Balloon angioplasty was performed in 8/19 cases (42%).Complete aneurysm neck coverage and adequate vesselwall apposition was obtained in all 19 cases withoutacute morbidity or mortality. An advantage of Surpassflow diverter is the Surpass delivery system that allows fora torque-free, over-the-wire deployment of the device.36

Additionally, this system provides the safety of maintain-ing a continuous endoluminal wire access that isuncoupled from the device deployment.

Other flow divertersSilkThe Silk is a self-expandable stent consisting of a tightlywoven structure, supplied with a soft microcatheter andhas resheathing and relocation abilities. For the majorityof studies in the literature, Silk is used for large andgiant neck fusiform aneurysms with a wide neck(dome-to-neck ratio of <2 mm or neck >4 mm). Straussand Maimon37 retrospectively reviewed patient data

from 2008 to 2013 and identified 60 patients with 67aneurysms (15 posterior circulation, 52 anterior circula-tion). They concluded a ‘good’ angiographic result in88% or 53/60 aneurysms, with a good outcome definedas complete or near-complete angiographic occlusion at15 months. The group identified aneurysm size as a posi-tive predictor of complication rate (0% in smaller aneur-ysms, 16.7% in large aneurysms and 42.9% in giantaneurysms). Giant aneurysms of the posterior circulationhad unfavourable results, with 57% complication ratedue to brainstem ischaemia secondary to perforatorocclusion.37 These data are further corroborated byLubicz et al,38 who reported a 11% delayed complicationrate with overall neurological morbidity of 5.5%;however, all complications were reported with the first-generation Silk device. In an eight-centre study inCanada by Shankar and colleagues, perioperative mor-bidity and mortality were 8.7% and 2.2%, respectively. Atthe last available follow-up, 83.1% of the aneurysms wereeither completely or near completely occluded, with therate of complications was higher for fusiform aneurysms(p<0.001).39

Taken together, these data show a trend towards betteroutcomes for smaller and anterior circulation aneurysmsand overall consistent radiographic outcomes for flowdiversion of large and/or fusiform aneurysms with theSilk device.

Flow-Redirection Endoluminal DeviceThe FRED system is flow diverter with a compliantclosed-cell paired stent (aka ‘stent within a stent’) com-posed of single wire braid self-expanding nickel titan-ium. Initial experience with this device remains limited.Diaz et al40 reviewed 13 patients with 14 treated aneur-ysms. Although no long-term angiographic data areavailable, there were no technical or immediate postpro-cedural complications. The authors concluded thedevice was technically easy to deploy and articulates theability for the device to be recaptured after partialdeployment and to maintain its internal shape in tortu-ous vessels as particular advantage. Long-term clinicaland angiographic clinical studies are necessary tofurther study this device.

p64The p64 Flow Modulation Device is a braided mesh tubecomposed of a 64 nickel–titanium nitinol alloy. Thedevice is compatible with a 0.027″ ID microcatheter. It isavailable in sizes 2.5–5 mm diameter with 12–36 mmlength. There are limited clinical data on this flow diver-ter, with an initial experience and technical aspectsreported by Briganti and colleagues. In their series ofsix intracranial aneurysms, immediate post-treatmentangiography showed reduced flow into all aneurysms,although no long-term angiographic data are available.41

The authors reported no periprocedural technical com-plications and no early or delayed aneurysm rupture, noischaemic or haemorrhagic complications, and no

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neurological morbidity or deaths. The authors note thatthe mechanical detachment feature, with 100% retriev-ability, is a potential advantage of this new device.41

Tubridge flow diverterThe Tubridge is a flow diverter developed by MicroPortMedical Company and is a braided, self-expandingstent-like device with flared ends. A large Tubridge(diameter ≥3.5 mm) is braided with 62 nickel–titaniummicrofilaments and 2 platinum–iridium radiopaquemicrofilaments, whereas a smaller Tubridge (diameter<3.5 mm) is composed of 46 nitinol and 2 platinum–

iridium microfilaments. Initial experience from Zhouet al42 on 28 patients with large or giant ICA aneurysmsshowed a 0% morbidity and mortality rate periprocedu-rally. At a mean follow-up of 10 months, 72% of theaneurysms were completely occluded and 24% wereimproved, with 4% showing no significant change.42

After approval from the Chinese FDA, the device is cur-rently being studied in a multicentre, randomised, con-trolled clinical trial.43 In this study, Zhou et al will enrol124 patients and randomise into a treatment group con-sisting of Tubridge or Tubridge with coils versus acontrol group treated with stent-assisted coiling.

INTRASACCULAR FLOW DISRUPTION AND THE WOVENENDOBRIDGE DEVICEFlow diversion has proven promising to overcome limita-tions of traditional endovascular coiling techniques forthe treatment of sidewall aneurysms; however, themanagement of large bifurcation aneurysms remains achallenge. For these bifurcation aneurysms, coiling with

adjunctive devices such as temporary balloon protectionor stent assistance are associated with increased proced-ural complexity, which lead to a higher chance ofcomplications. Additionally, use of stents requiresperiprocedural dual-antiplatelet therapy with inherentrisks of haemorrhage. In this context, a new device wasdeveloped to provide an innovative alternative strategyvia intrasaccular flow disruption called the WovenEndoBridge (WEB; Sequent Medical, Aliso Viejo,California, USA). The WEB is a self-expanding, oblate,braided mesh of nitinol wires that is deployed into theaneurysm sac itself (figure 3). The initial WEB deviceconsisted of a dual layer (WEB DL) design of inner andouter braids; however, this has since evolved to a singlelayer (WEB SL) device with a higher number of nitinolwires providing similar flow disruption effects.44 Prior todetachment of the WEB device, it can be fully retrieved.Additional modifications of the WEB SL device include aspherical shape (WEB SLS) and enhanced visualisation(WEB EV) provided by platinum-cored nitinol wires.Once a WEB device is deployed within the aneurysm sac,the WEB modifies the blood flow at the aneurysm neck,which induces thrombosis within the aneurysm. Figure 4demonstrates two case examples of middle cerebral artery(MCA) bifurcation aneurysms treated with the WEBdevice.Several retrospective institutional studies in Europe

have demonstrated the initial safety and efficacy ofthe WEB device.44–47 Given the promising data, twoprospective, good clinical practice series were con-ducted in Europe: WEBCAST and French Observatory.These single-arm, prospective, multicentre studiesincluded ruptured and unruptured bifurcation

Figure 3 WEB intrasaccular flow disruption system. SL, single layer; WEB, Woven EndoBridge; WEB SLS, WEB SL device with

a spherical shape. Images provided by Sequent Medical.

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aneurysms located in the basilar artery, middle cere-bral artery, anterior communicating artery and ICAterminus.48 Postoperative, 6-month (in WEBCAST)and 1-year aneurysm occlusion was independentlyevaluated with a three-grade scale: complete occlu-sion, neck remnant and aneurysm remnant. A total of113 patients with 114 aneurysms were treated. Therewas no mortality at 1 month, and morbidity was 2.7%.At 1 year, complete aneurysm occlusion was observedin 56.0%, neck remnant in 26.0% and aneurysmremnant in 18.0%. Worsening of aneurysm occlusionbetween the procedure and 12 months was observedin 2.0% and between 6 months and 1 year in 7.1%.48

The combination of these two prospective studies repre-sents the largest series of WEB cases in the literature. Theadvantage of the WEB device is the combination of anendosaccular approach with flow diversion. This elimi-nates the need for dual antiplatelet therapy required forendoluminal devices and subsequently allows use in theruptured aneurysm setting with subarachnoid haemor-rhages. Although the data are encouraging, the availabil-ity of the WEB device is still limited primarily to Europeand South America. In the USA, the multicentre clinicaltrial for premarket approval of the WEB completed enrol-ment in November 2015 and the data from the trial arestill being collected.

NEUROENDOVASCULAR CATHETER ACCESS SYSTEMAs neurointervention evolves with innovative devicessuch as flow diverters and intrasaccular devices, catheter

access systems have also become more sophisticated.Fundamental to any neurointervention is the need for astable catheter access and delivery system that offersvarying degrees of trackability, distal and proximalsupport, and precise distal targeting. In essence,increased guide catheter support is required for proce-dures with larger device delivery systems, tortuousanatomy and distal targets.Classically, neurointerventions were performed using a

biaxial system consisting of a relatively rigid guide cath-eter (eg, Envoy) positioned in the cervical ICA and asmall flexible microcatheter that was advanced intracra-nially to the target of interest. Often the microcatheterhas to be advanced a considerable distance from thesupporting guide catheter, thereby reducing the controland tactile feedback for the operator and increasing thepropensity for unwanted slack in the system. These lim-itations are amplified in older patients with significantvessel tortuosity, and it can lead to technical failures thatnecessitate alternative more invasive approaches such asdirect carotid puncture.There has been a paradigm shift in the design and

approach to catheter support systems for cases of flowdiversion from a classic biaxial set-up with cervical posi-tioning of guide catheters to a more robust triaxialsystem with intracranial positioning of intermediatesupport catheters. This is secondary to the comparativelylarger size of the flow diverter delivery microcatheter(0.027″ ID for the PED) and the significant intradeploy-ment manipulations required for proper device implant-ation. The Navien (Medtronic Neurovascular, Irvine,

Figure 4 WEB treatment of MCA bifurcation aneurysms. Top row is a small left MCA bifurcation aneurysm. Bottom row is a

large right MCA bifurcation aneurysm. WEB, Woven EndoBridge. Images provided by Sequent Medical.

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California, USA) is a newer generation 5 French (0.058″ID) distal intracranial catheter that is highly trackableand atraumatic with a large bore lumen that can accom-modate 0.027″ ID delivery microcatheters used for flowdiverters with added room for flush and contrast injec-tions. There has been significant experience with theNavien for use in a variety of endovascular aneurysmtreatments, including PED as well as stent-assistedcoiling. These experiences demonstrate successful track-ability of the catheter consistently to intracranial loca-tions such as the ICA and MCA despite vesseltortuosity.49 50 The Navien catheter has also been instru-mental when used as a salvage technique for caseswhere PED opening fails with standard deploymentmanoeuvres.51

This paradigm shift towards more robust multiaxialcatheter support systems has ushered the developmentof additional new intermediate support catheters similarto the Navien catheter. One such example is the Catalystclass of intermediate catheters (Stryker Neurovascular,Freemont, California, USA). The 5 French Catalyst hasdemonstrated significant advantages of enhanced track-ability with reliable stable intracranial support for deliv-ery of modern neuroendovascular devices, includingflow diverters such as the PED Flex and Surpass, as wellas the intrasaccular devices such as the WEB (seniorauthors’ experience, unpublished data). The import-ance of stable catheter support systems translates toimproved safety and ease for sophisticated neurointer-ventional treatments.

PENDING NEW TECHNOLOGYAn array of potential new technology is on the horizonfor the neurointerventional field. These include coatedflow diverters for reduced thrombogenicity, self-expanding three-dimensional mesh endosaccular devicecalled the Medina (Medtronic Neurovascular, Irvine,California, USA), smaller profile WEB devices to addressbroader range of aneurysm sizes (figure 5), and an add-itional new intrasaccular flow disrupter called the Artisdevice (Medtronic Neurovascular, Irvine, California,USA). These new technologies will continue to expandthe neuroendovascular tools available to treat a widevariety of aneurysm types with improved safety and

efficacy. It is fair to say the management of intracranialaneurysms is constantly evolving, with sophisticated tech-nology at the forefront of innovation.

Contributors BJ drafted the manuscript. MP provided illustration of the flowdiversion concept. GPC and ALC assisted in critically revising the manuscript.L-ML conceived of the manuscript and critically reviewed the importantintellectual content. All authors read and approved the final manuscript.

Competing interests ALC is a proctor for the Pipeline Embolization Device(Medtronic Neurovascular, Irvine, California, USA) and a consultant forMedtronic; a proctor for the Surpass device (Stryker Neurovascular, Fremont,California, USA) and a consultant for Stryker Neurovascular; a proctor for theFlow-Redirection Endoluminal Device (FRED) device (Microvention, Tustin,California, USA) and a consultant for Microvention; a proctor for the WovenEndoBridge (WEB) device (Sequent Medical, Aliso Viejo, California, USA) anda consultant for Sequent. GPC is a consultant for Medtronic Neurovascularand Microvention.

Provenance and peer review Commissioned; externally peer reviewed.

Data sharing statement No additional data are available.

Open Access This is an Open Access article distributed in accordance withthe Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license,which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, providedthe original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

REFERENCES1. Dandy WE. Intracranial aneurysm of the internal carotid artery: cured

by operation. Ann Surg 1938;107:654–9.2. Molyneux A, Kerr R, International Subarachnoid Aneurysm Trial

Collaborative G, et al. International Subarachnoid Aneurysm Trial(ISAT) of neurosurgical clipping versus endovascular coiling in 2143patients with ruptured intracranial aneurysms: a randomized trial.J Stroke Cerebrovasc Dis 2002;11:304–14.

3. Spetzler RF, McDougall CG, Zabramski JM, et al. The BarrowRuptured Aneurysm Trial: 6-year results. J Neurosurg2015;123:609–17.

4. Raymond J, Guilbert F, Weill A, et al. Long-term angiographicrecurrences after selective endovascular treatment of aneurysmswith detachable coils. Stroke 2003;34:1398–403.

5. Gory B, Turjman F. Endovascular treatment of 404 intracranialaneurysms treated with nexus detachable coils: short-term andmid-term results from a prospective, consecutive, Europeanmulticenter study. Acta Neurochir (Wien) 2014;156:831–7.

6. Brinjikji W, White PM, Nahser H, et al. HydroCoils are associatedwith lower angiographic recurrence rates than are bare platinum coilsin treatment of “difficult-to-treat” aneurysms: a post hoc subgroupanalysis of the HELPS trial. AJNR Am J Neuroradiol2015;36:1689–94.

7. Taschner CA, Chapot R, Costalat V, et al. GREAT-a randomizedcontrolled trial comparing HydroSoft/HydroFrame and bare platinumcoils for endovascular aneurysm treatment: procedural safety andcore-lab-assessedangiographic results. Neuroradiology PublishedOnline First: 30 Apr 2016. doi:10.1007/s00234-016-1693-y

Figure 5 Optimisation of WEB

platform. WEB, Woven

EndoBridge. Images provided by

Sequent Medical.

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on June 10, 2020 by guest. Protected by copyright.

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/S

troke Vasc N

eurol: first published as 10.1136/svn-2016-000027 on 17 August 2016. D

ownloaded from

Page 8: Cerebral aneurysm treatment: modern neurovascular techniques · intracranial aneurysms, these aneurysms only encompass a small fraction of all intracranial aneurysms. In contrast,

8. Akpek S, Arat A, Morsi H, et al. Self-expandable stent-assistedcoiling of wide-necked intracranial aneurysms: a single-centerexperience. AJNR Am J Neuroradiol 2005;26:1223–31.

9. Colby GP, Paul AR, Radvany MG, et al. A single center comparisonof coiling versus stent assisted coiling in 90 consecutiveparaophthalmic region aneurysms. J Neurointerv Surg2012;4:116–20.

10. Piotin M, Blanc R, Spelle L, et al. Stent-assisted coiling ofintracranial aneurysms: clinical and angiographic results in 216consecutive aneurysms. Stroke 2010;41:110–15.

11. Dengler J, Maldaner N, Glasker S, et al. Outcome of surgical orendovascular treatment of giant intracranial aneurysms, withemphasis on age, aneurysm location, and unruptured aneurysms—asystematic review and meta-analysis. Cerebrovasc Dis2016;41:187–98.

12. Hauck EF, Welch BG, White JA, et al. Stent/coil treatment of verylarge and giant unruptured ophthalmic and cavernous aneurysms.Surg Neurol 2009;71:19–24; discussion 24.

13. Aenis M, Stancampiano AP, Wakhloo AK, et al. Modeling of flow in astraight stented and nonstented side wall aneurysm model.J Biomech Eng 1997;119:206–12.

14. Hoi Y, Ionita CN, Tranquebar RV, et al. Flow modification in canineintracranial aneurysm model by an asymmetric stent: studies usingdigital subtraction angiography (DSA) and image-basedcomputational fluid dynamics (CFD) analyses. Proc SPIE Int SocOpt Eng 2006;6143:61430J.

15. Krishna C, Sonig A, Natarajan SK, et al. The expanding realm ofendovascular neurosurgery: flow diversion for cerebral aneurysmmanagement. Methodist Debakey Cardiovasc J 2014;10:214–19.

16. Nelson PK, Lylyk P, Szikora I, et al. The pipeline embolizationdevice for the intracranial treatment of aneurysms trial. AJNR AmJ Neuroradiol 2011;32:34–40.

17. Administration. UFaD. Pipeline embolization device PMA P100018.Summary of safety and effectiveness data. 2011. http://www.accessdata.fda.gov/cdrh_docs/pdf10/p100018b.pdf

18. Colby GP, Lin LM, Caplan JM, et al. Immediate procedural outcomesin 44 consecutive Pipeline Flex cases: the first North Americansingle-center series. J Neurointerv Surg 2016;8:702–9.

19. Lylyk P, Miranda C, Ceratto R, et al. Curative endovascularreconstruction of cerebral aneurysms with the pipeline embolizationdevice: the Buenos Aires experience. Neurosurgery2009;64:632–42; discussion 42–3; quiz N6.

20. Szikora I, Berentei Z, Kulcsar Z, et al. Treatment of intracranialaneurysms by functional reconstruction of the parent artery: theBudapest experience with the pipeline embolization device. AJNRAm J Neuroradiol 2010;31:1139–47.

21. Becske T, Kallmes DF, Saatci I, et al. Pipeline for uncoilable or failedaneurysms: results from a multicenter clinical trial. Radiology2013;267:858–68.

22. Colby GP, Lin LM, Gomez JF, et al. Immediate procedural outcomesin 35 consecutive pipeline embolization cases: a single-center,single-user experience. J Neurointerv Surg 2013;5:237–46.

23. Colby GP, Lin LM, Paul AR, et al. Cost comparison of endovasculartreatment of anterior circulation aneurysms with the pipelineembolization device and stent-assisted coiling. Neurosurgery2012;71:944–8; discussion 48–50.

24. Colby GP, Lin LM, Nundkumar N, et al. Radiation dose analysis oflarge and giant internal carotid artery aneurysm treatment with thepipeline embolization device versus traditional coiling techniques.J Neurointerv Surg 2015;7:380–4.

25. Investigators UJ, Morita A, Kirino T, et al. The natural course ofunruptured cerebral aneurysms in a Japanese cohort. N Engl J Med2012;366:2474–82.

26. Wiebers DO, Whisnant JP, Huston J III, et al. Unruptured intracranialaneurysms: natural history, clinical outcome, and risks of surgicaland endovascular treatment. Lancet 2003;362:103–10.

27. Roessler K, Cejna M, Zachenhofer I. Aneurysmatic subarachnoidalhaemorrhage: incidence and location of small ruptured cerebralaneurysms—a retrospective population-based study. Wien KlinWochenschr 2011;123:444–9.

28. Lin LM, Colby GP, Kim JE, et al. Immediate and follow-up results for44 consecutive cases of small (<10 mm) internal carotid arteryaneurysms treated with the pipeline embolization device. SurgNeurol Int 2013;4:114.

29. Chan TT, Chan KY, Pang PK, et al. Pipeline embolisation devicefor wide-necked internal carotid artery aneurysms in a hospital inHong Kong: preliminary experience. Hong Kong Med J2011;17:398–404.

30. Lubicz B, Collignon L, Raphaeli G, et al. Pipeline flow-diverter stentfor endovascular treatment of intracranial aneurysms: preliminaryexperience in 20 patients with 27 aneurysms. World Neurosurg2011;76:114–19.

31. Albuquerque FC, Park MS, Abla AA, et al. A reappraisal of thePipeline embolization device for the treatment of posterior circulationaneurysms. J Neurointerv Surg 2015;7:641–5.

32. Brouillard AM, Sun X, Siddiqui AH, et al. The use of flow diversionfor the treatment of intracranial aneurysms: expansion of indications.Cureus 2016;8:e472.

33. Chalouhi N, Zanaty M, Whiting A, et al. Safety and efficacy of thePipeline Embolization Device in 100 small intracranial aneurysms.J Neurosurg 2015;122:1498–502.

34. Briganti F, Leone G, Marseglia M, et al. Endovascular treatment ofcerebral aneurysms using flow-diverter devices: a systematic review.Neuroradiol J 2015;28:365–75.

35. Wakhloo AK, Lylyk P, de Vries J, et al. Surpass flow diverter in thetreatment of intracranial aneurysms: a prospective multicenter study.AJNR Am J Neuroradiol 2015;36:98–107.

36. Colby GP, Lin LM, Caplan JM, et al. Flow diversion of large internalcarotid artery aneurysms with the surpass device: impressions andtechnical nuance from the initial North American experience.J Neurointerv Surg 2016;8:279–86.

37. Strauss I, Maimon S. Silk flow diverter in the treatment of complexintracranial aneurysms: a single-center experience with 60 patients.Acta Neurochir (Wien) 2016;158:247–54.

38. Lubicz B, Van der Elst O, Collignon L, et al. Silk flow-diverter stentfor the treatment of intracranial aneurysms: a series of 58 patientswith emphasis on long-term results. AJNR Am J Neuroradiol2015;36:542–6.

39. Shankar JJ, Tampieri D, Iancu D, et al. SILK flow diverter forcomplex intracranial aneurysms: a Canadian registry. J NeurointervSurg 2016;8:273–8.

40. Diaz O, Gist TL, Manjarez G, et al. Treatment of 14 intracranialaneurysms with the FRED system. J Neurointerv Surg2014;6:614–17.

41. Briganti F, Leone G, Marseglia M, et al. p64 Flow Modulation Devicein the treatment of intracranial aneurysms: initial experience andtechnical aspects. J Neurointerv Surg 2016;8:173–80.

42. Zhou Y, Yang PF, Fang YB, et al. A novel flow-diverting device(Tubridge) for the treatment of 28 large or giant intracranialaneurysms: a single-center experience. AJNR Am J Neuroradiol2014;35:2326–33.

43. Zhou Y, Yang PF, Fang YB, et al. Parent artery reconstruction forlarge or giant cerebral aneurysms using a Tubridge flow diverter(PARAT): study protocol for a multicenter, randomized, controlledclinical trial. BMC Neurol 2014;14:97.

44. Pierot L, Liebig T, Sychra V, et al. Intrasaccular flow-disruptiontreatment of intracranial aneurysms: preliminary results of amulticenter clinical study. AJNR Am J Neuroradiol 2012;33:1232–8.

45. Mine B, Pierot L, Lubicz B. Intrasaccular flow-diversion for treatmentof intracranial aneurysms: the Woven EndoBridge. Expert Rev MedDevices 2014;11:315–25.

46. Papagiannaki C, Spelle L, Januel AC, et al. WEB intrasaccular flowdisruptor-prospective, multicenter experience in 83 patients with 85aneurysms. AJNR Am J Neuroradiol 2014;35:2106–11.

47. Pierot L, Klisch J, Cognard C, et al. Endovascular WEB flowdisruption in middle cerebral artery aneurysms: preliminaryfeasibility, clinical, and anatomical results in a multicenter study.Neurosurgery 2013;73:27–34; discussion 34–5.

48. Pierot L, Spelle L, Molyneux A, et al., WEBCAST and FrenchObservatory Investigators. Clinical and anatomical follow-up inpatients with aneurysms treated with the WEB device: 1-yearfollow-up report in the cumulated population of 2 prospective,multicenter series (WEBCAST and French Observatory).Neurosurgery 2016;78:133–41.

49. Colby GP, Lin LM, Huang J, et al. Utilization of the Navien distalintracranial catheter in 78 cases of anterior circulation aneurysmtreatment with the Pipeline embolization device. J Neurointerv Surg2013;5(Suppl 3):iii16–21.

50. Lin LM, Colby GP, Huang J, et al. Ultra-distal large-bore intracranialaccess using the hyperflexible Navien distal intracranial catheter forthe treatment of cerebrovascular pathologies: a technical note.J Neurointerv Surg 2014;6:301–7.

51. Lin LM, Colby GP, Jiang B, et al. Intra-DIC (distal intracranialcatheter) deployment of the Pipeline embolization device: a novelrescue strategy for failed device expansion. J Neurointerv Surg2016;8:840–6.

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